FDAFDA · Food and drugs·Recall number D-1430-2015
Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville LLC Gainesville, GA 30504 for Sandoz Inc. Princeton, NJ 08540
Published September 23, 2015 · Recall initiated: July 28, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Dissolution Specifications: Product is being recalled due to out of specification (above specification) result obtained at 6-hour dissolution time point during the 12-month stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Distributor
- NJ - site for distributor
- Lot
- Lot #: F0002, Exp 12/2016
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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